Inspectors/investigators are the eyes and ears for boards of pharmacy, ensuring compliance with pharmacy law and practice standards. In this feature, inspectors reveal what they’ve learned in the field.
James ‘Jay’ Queenan, RPh
Compliance Investigator/Inspector, New Hampshire Board of Pharmacy
How long have you been serving as an inspector for the Board? What was your role prior to working for the Board?
I have been a New Hampshire Board of Pharmacy inspector since January 2014. Prior to that, I was executive secretary of the Board for five years. I have been in middle management as a pharmacy operations manager for a supermarket chain, a community pharmacist for that same chain, and an independent retail pharmacist. I started working for my dad and uncle in our family pharmacy as a teenager. Presently, my role at the Board has two major components. I, along with my colleagues, Elsa Croteau and Robert Elder, proactively inspect all in-state pharmacies annually for state and federal compliance. The second part of my position is to investigate complaints to the Board regarding pharmacy practice. Sometimes, investigations involve drug diversion.
In your opinion, what tools or skills are a must-have in a pharmacy inspector’s toolkit?
Certainly, a strong background in pharmacy practice and logistics of pharmacy as a business entity is necessary. A strong working knowledge of state and federal regulation is also a must. Being innately inquisitive and observant is very valuable. When I took this position, I needed to improve my writing skills. Being able to write a concise, detailed report that is easy to read and understand is challenging. It is imperative to keep good records; that is not very exciting, but it separates the good inspectors from the mediocre.
What are some common issues that you have witnessed and addressed as an inspector with the Board?
In the aftermath of the New England Compounding Center crisis, New Hampshire has taken an aggressive stance on inspecting sterile compounding pharmacies. Nearly all the hospital pharmacies in the state have remodeled or added new cleanrooms. The hospital directors and sterile compounders in the state have really improved their practice and policies. Huge strides in patient safety are the outcome.
When the Board implements new rules, I find myself educating the pharmacy community about the new rule and facilitating compliance. Two examples that come to mind are the mandated pharmacist break time rules and the new quality assurance program.
In New Hampshire, do inspectors also conduct investigations for other health regulatory boards?
The Board inspects practitioners and entities that are not licensed by the Board and, of course, those entities that are. We inspect practitioner offices, animal hospitals, veterinarians, naturopathic practitioners, methadone clinics, public health clinics, and others. Our focus is primarily on prescription medication. Should we note a violation, we forward the notification to the appropriate board for action.
It is very interesting to inspect drug wholesalers, medical gas facilities, correctional institutes, and methadone clinics. I truly love the diversity of my position. I meet so many skilled and committed professionals and learn something new daily. I have seen hypodermic needles being manufactured, watched a veterinarian perform eye surgery on a dog, taught a class at the local college of pharmacy, and represented New Hampshire at Food and Drug Administration intergovernmental working meetings. Also, I have reviewed hundreds of Multistate Pharmacy Jurisprudence Examination® questions, testified before state legislators, walked through the exercise yard at the state prison, and traveled to every corner of this beautiful state by car. Never a dull moment!
What advice would you give to a new board inspector?
Bring your sense of humor and your values to the job. When performing an investigation, look beyond the obvious and don’t jump to conclusions. Ask questions, especially ones you think you know the answer to before asking. There are several sides (the four compass points and up and down) to every incident. Organize your time. Remember your role – patient safety through compliance.
This article is featured in the March 2020 Innovations.